DOBUTAMINE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)

Available from:

Hospira, Inc.

INN (International Name):

DOBUTAMINE HYDROCHLORIDE

Composition:

DOBUTAMINE 12.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to Dobutamine Injection, USP solution.

Product summary:

Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials containing 250 mg dobutamine, as the hydrochloride as follows: Store at 20 to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOBUTAMINE- DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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DOBUTAMINE
INJECTION, USP
FLIPTOP VIAL
R only
MUST BE DILUTED PRIOR TO
ADMINISTRATION
DESCRIPTION
Dobutamine Injection, USP is a clear, practically colorless, sterile,
nonpyrogenic solution of
dobutamine hydrochloride for intravenous use only. Each milliliter
contains 12.5 mg (41.5 µmol)
dobutamine, as the hydrochloride and sodium metabisulfite, 0.2 mg
added as antioxidant. May contain
hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 3.3
(2.5 to 5.5).
Dobutamine Hydrochloride, USP is chemically designated
(±)-4-[2-[[3-(ρ-hydroxyphenyl)-1-
methylpropyl] amino]ethyl]-pyrocatechol hydrochloride.
It is a synthetic catecholamine.
Molecular Weight: 337.85
Molecular Formula: C
H NO • HCl
CLINICAL PHARMACOLOGY
Dobutamine hydrochloride is a direct-acting inotropic agent whose
primary activity results from
stimulation of the β receptors of the heart while producing
comparatively mild chronotropic,
hypertensive, arrhythmogenic, and vasodilative effects. It does not
cause the release of endogenous
norepinephrine, as does dopamine. In animal studies, dobutamine
hydrochloride produces less increase
in heart rate and less decrease in peripheral vascular resistance for
a given inotropic effect than does
isoproterenol.
In patients with depressed cardiac function, both dobutamine
hydrochloride and isoproterenol increase
the cardiac output to a similar degree. In the case of dobutamine
hydrochloride, this increase is usually
not accompanied by marked increases in heart rate (although
tachycardia is occasionally observed), and
the cardiac stroke volume is usually increased. In contrast,
isoproterenol increases the cardiac index
primarily by increasing the heart rate while stroke volume changes
little or declines.
Facilitation of atrioventricular conduction has been observed in human
electrophysiologic studies and
in patients with atrial fibrillation.
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18
23
3
Systemic vascular resistance is usually decreased with administration